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Change in location of Pulmonary Rehab at our institution
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To investigate Phonation therapy to improve symptoms and lung physiology in patients referred for pulmonary rehabilitation. The study design will be a randomized controlled trial. The primary outcome is improvement in patient symptoms (Borg dyspnea score). Secondary outcomes are improvement in time of breath hold, forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), negative inspiratory force (NIF) and improvement in quality of life. The investigators will be investigating tonation breathing techniques (TBT) exercises and music-driven vocal exercises (MDVE). The study population would be patients who are referred to pulmonary rehabilitation (PR) for symptomatic chronic lung disease. The calculated sample size for the study would be 16 patients and the duration of the study would be 8 weeks. The study would be performed after the participant's pulmonary rehabilitation session.
Patients who are referred for pulmonary rehabilitation for chronic lung disease and/or post-COVID19 therapy, and who have had pulmonary function testing already will be approached. Pulmonary rehabilitation is an 8-week program (meeting 3 times per week for the 8 weeks). Pulmonary rehabilitation (PR) is the standard of care for patients with chronic lung diseases and or post-COVID-19 therapy. Eligible study participants will be called prior to their introductory PR session to explain the research project, and those who are interested will be given full information and offered time to ask questions. The investigators find this necessary for logistics, given many of the PR patients rely on scheduled transportation to/from PR and this will allow those who are interested in obtaining more information and to consent to the study to arrange for appropriate transportation. Informed consent will be done in person on an individual basis at their introductory PR session, with 1:1 discussion with the study staff and the patient.
As this is a pilot study to determine feasibility, and preliminary data (as no data are currently available for this patient population), the investigators propose 16 participants in total, 4 in each arm of the study. Randomization will occur by random number generator (1-4 for each arm proposed).
Once informed consent is obtained, patients will be randomized to 4 arms of the study. Randomization will be performed using a random number generator.
Comparing tonation breathing technique (TBT) to normal breathing:
Comparing MDVE to normal breathing:
These interventions would be performed after the usual PR time when patients would be normally discharged home. Therefore, no additional monitoring is expected.
Pulmonary function testing is standard for all patients who receive PR - testing before and after PR is routine clinical course. The investigators propose an additional pulmonary function test (PFT) study at 4 weeks, as part of the research protocol (covered by the Department of Medicine funding)
In summary, the interventions for research purposes will include:
Proposed subjective outcomes are routinely asked of PR patients, but will be collected at baseline, at 4 weeks (mid-way), and at 8 weeks (end) of PR. Proposed objective outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silent Breathing / Tonation Breathing Techniques (TBT) | Experimental | Twice a week during the patient's 8 weeks of pulmonary rehabilitation:
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| Silent Breathing / Music Driven Vocal Exercises (MDVE) | Experimental | Twice a week during the patient's 8 weeks of pulmonary rehabilitation:
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| Tonation Breathing Techniques (TBT) / Silent Breathing | Experimental | Twice a week during the patient's 8 weeks of pulmonary rehabilitation:
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| Music Driven Vocal Exercises (MDVE) / Silent Breathing | Experimental | Twice a week during the patient's 8 weeks of pulmonary rehabilitation:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tonation Breathing Techniques | Behavioral | Tonation and Breathing Techniques (TBT): consist of a combination of organic inhalation and controlled exhalation with tonation. This will be guided by a trained facilitator, and the entire exercise will take 20 minutes. This will include guided relaxed breathing, mindful breathing, patterned tonation, nasal tonation, and pursed lip tonation. |
| Measure | Description | Time Frame |
|---|---|---|
| Borg dyspnea score | subjective score of dyspnea | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | forced expiratory volume in 1 second | 4 and 8 weeks |
| Borg dyspnea score | subjective score of dyspnea | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
• Cannot commit to staying an extra 30 min after Pulmonary Rehabilitation sessions for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Vidya Krishnan, MD, MHS | Case Western Reserve University, MetroHealth Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16623646 | Background | Ostermann T, Schmid W. Music therapy in the treatment of multiple sclerosis: a comprehensive literature review. Expert Rev Neurother. 2006 Apr;6(4):469-77. doi: 10.1586/14737175.6.4.469. | |
| 30471799 | Background | Garcia-Casares N, Martin-Colom JE, Garcia-Arnes JA. Music Therapy in Parkinson's Disease. J Am Med Dir Assoc. 2018 Dec;19(12):1054-1062. doi: 10.1016/j.jamda.2018.09.025. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 1, 2022 | Jan 12, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Randomized control trial. Randomization for each subject occurs twice. First: One of two types of intervention. Second: Sequence for intervention and normal breathing sessions.
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| Music Driven Vocal Exercises | Behavioral | Music Driven Vocal Exercises (MDVE): A Music Therapy procedure will be implemented by a trained facilitator, utilizing an accompanying instrument (ie, guitar or Autoharp) and moving stepwise up and down within a scale of 8 whole steps. The total length of the procedure is 20-25 minutes. This will include vocal exercises, and melodic exercises alternating with speaking, |
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| Silent Breathing | Behavioral | Patient will sit in a quiet room and focus on silent breathing x 20 min. |
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| Breath hold | time in seconds participant can hold breath | 4 weeks, 8 weeks |
| quality of life (QOL) | questionnaire on quality of life | 4 weeks, 8 weeks |
| forced vital capacity (FVC) | forced vital capacity | 4 weeks, 8 weeks |
| peak flow | peak flow | 4 weeks, 8 weeks |
| negative inspiratory force (NIF) | negative inspiratory force | 4 weeks, 8 weeks |
| 26522499 | Background | Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19. |
| Background | Mathis DR. Melodic sculpturing: the art and science of singing. Bloomington, IN: AuthorHouse, 2009 |
| Background | Price, Kate. The effects of vocal function exercises on the lung function of trained female singers: a pilot investigation. Diss. Victoria University, 2003. |
| 29253921 | Background | McNamara RJ, Epsley C, Coren E, McKeough ZJ. Singing for adults with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2017 Dec 19;12:CD012296. doi: 10.1002/14651858.CD012296.pub2. |
| 13655288 | Background | DRAPER MH, LADEFOGED P, WHITTERIDGE D. Respiratory muscles in speech. J Speech Hear Res. 1959 Mar;2(1):16-27. doi: 10.1044/jshr.0201.16. No abstract available. |
| 5934452 | Background | Bouhuys A, Proctor DF, Mead J. Kinetic aspects of singing. J Appl Physiol. 1966 Mar;21(2):483-96. doi: 10.1152/jappl.1966.21.2.483. No abstract available. |
| Background | Leanderson, R.; Sundberg, J. (1988). Breathing for singing. , 2(1), 2-12. doi:10.1016/S0892-1997(88)80051-1 |
| 3558185 | Background | Leanderson R, Sundberg J, von Euler C. Role of diaphragmatic activity during singing: a study of transdiaphragmatic pressures. J Appl Physiol (1985). 1987 Jan;62(1):259-70. doi: 10.1152/jappl.1987.62.1.259. |
| 33144384 | Background | Huang J, Yuan X, Zhang N, Qiu H, Chen X. Music Therapy in Adults With COPD. Respir Care. 2021 Mar;66(3):501-509. doi: 10.4187/respcare.07489. Epub 2020 Nov 3. |
| 22397390 | Background | Sliwka A, Nowobilski R, Polczyk R, Nizankowska-Mogilnicka E, Szczeklik A. Mild asthmatics benefit from music therapy. J Asthma. 2012 May;49(4):401-8. doi: 10.3109/02770903.2012.663031. Epub 2012 Mar 7. |
| Background | Morrison, Ian, and S. M. Clift. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |